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Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels

Sponsor
DOMCA S.A. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04646382
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
22.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune system will also be analyzed.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Garlic and onion concentrate
  • Dietary Supplement: Control
 N/A

Detailed Description

It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.

64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups: control group and intervention group.

For 8 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.

Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and health-related data were also measured.

Parameters related to lipid metabolism, metabolic syndrome and the immune system will be analized.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Controlled, randomized, double-blind, parallel group nutritional intervention study.Controlled, randomized, double-blind, parallel group nutritional intervention study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Each volunteer is assigned a "participant number" that will be associated with a pot that will have all the product for the study. The "pot number" is the same as the "participant number".
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effect of Consuming a Mixture of Concentrated Allium Extracts on LDL Cholesterol Levels in Healthy Volunteers With Elevated LDL Cholesterol Levels
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 29, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Dietary Supplement: Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
  • AlioCare

    • Dietary Supplement: Control
    Microcrystalline cellulose
    Other Names:
  • Excipient

    		•
    Experimental: Intervention

    Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

    Dietary Supplement: Garlic and onion concentrate
    Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
    Other Names:
  • AlioCare

    • Dietary Supplement: Control
    Microcrystalline cellulose
    Other Names:
  • Excipient

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LDL [8 weeks.]

      Serum LDL cholesterol

    Secondary Outcome Measures

    1. Cholesterol [8 weeks]

      Serum total cholesterol

    2. HDL [8 weeks]

      Serum HDL cholesterol

    3. Triglycerides [8 weeks]

      Serum triglycerides

    4. Glucose [8 weeks]

      Serum glucose

    5. CRP [8 weeks]

      C-reactive protein in serum

    6. Oxidized LDL cholesterol [8 weeks]

      Oxidized LDL cholesterol in plasma

    7. MDA [8 weeks]

      Malondialdehyde in plasma

    8. TAC [8 weeks]

      Plasma total antioxidant capacity

    9. Selenium [8 weeks]

      Serun selenium

    10. Selenoprotein P [8 weeks]

      Selenoprotein P in plasma

    11. VCAM-1 [8 weeks]

      Endothelial adhesion molecules VCAM-1 in plasma

    12. ICAM-1 [8 weeks]

      Endothelial adhesion molecules ICAM-1 in plasma

    13. IL1 beta in plasma [8 weeks]

      Interleukin-1 beta in plasma

    14. IL 6 [8 weeks]

      Interleukin-6 in plasma

    15. IL 10 [8 weeks]

      Interleukin-10 in plasma

    16. BMI [8 weeks]

      Body mass index (height/weight ratio)

    17. Abdominal perimeter [8 weeks]

      Abdominal perimeter in centimeters

    18. Blood pressure [8 weeks]

      Systolic pressure and diastolic pressure)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • LDL-cholesterol levels between 100 and 190 mg/dL.

    • Freely agree to participate in the study and sign the informed consent document.

    Exclusion Criteria:

    • Be pregnant.

    • Have planned to change lifestyle and / or dietary habits.

    • Having diabetes.

    • Having a cerebrovascular disease.

    • Having a serious illness.

    • Taking products or drugs to control cholesterol levels or with antioxidant activity.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Domca Sau Alhendín Granada Spain 18620

    Sponsors and Collaborators

    • DOMCA S.A.

    Investigators

    • Principal Investigator: Miguel Quesada, MD, Endocrinology and Nutrition Clinic of Dr. Miguel Quesada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DOMCA S.A.
    ClinicalTrials.gov Identifier:
    NCT04646382
    Other Study ID Numbers:
    • C003
    First Posted:
    Nov 30, 2020
    Last Update Posted:
    May 23, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DOMCA S.A.
    Garlic
    Onion
    LDL cholesterol
    Cardiovascular health

    Study Results

    No Results Posted as of May 23, 2022